🚀 𝗦𝗼𝗺𝗲𝘁𝗵𝗶𝗻𝗴 𝗯𝗶𝗴 𝗶𝘀 𝗰𝗼𝗺𝗶𝗻𝗴! 🚀 We’re on the verge of unveiling an essential resource designed to empower the regulatory writing community. Packed with expert-driven insights, actionable strategies, and pioneering perspectives, this tool aims to redefine how we approach the complexities of submissions and the evolving landscape of regulatory science. Whether advancing groundbreaking therapies or streamlining global compliance, this resource is your guide to staying ahead in a rapidly changing field. Stay connected—you’ll want to be part of this transformation. 👀 Drop your guesses in the comments below! 👇
About us
Certara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include 2,000 biopharmaceutical companies, academic institutions, and regulatory agencies across 62 countries.
- Website
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https://www.certara.com
External link for Certara
- Industry
- Business Consulting and Services
- Company size
- 1,001-5,000 employees
- Headquarters
- Radnor, Pennsylvania
- Type
- Public Company
- Specialties
- model-based drug discovery and development, scientific informatics, PK/PD modeling and simulation, PBPK modeling and simulation, trial design, drug development, regulatory writing, quantitative systems pharmacology, clinical pharmacology, quantitative systems toxicology, transparency and disclosure, model-based meta-analysis, regulatory strategy, regulatory publishing, market access, health economics and outcomes research, and real world evidence solutions
Locations
Employees at Certara
Updates
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In honor of Women’s History Month, join us as we highlight the voices of our women leaders and colleagues, starting with Hannah Jones, SVP, Head of Simcyp PBPK Modelling Services. She shares her insights on the advice she wishes she had received when beginning her career in science—valuable wisdom for those just starting their journey. ------------ "Believe in your abilities and never underestimate your worth. Too often, women feel the pressure to prove themselves or question whether they truly belong in a particular role. But the truth is, you are there because you deserve to be. Even when you're in the minority, remember that your ideas, contributions and approach to problem solving are what make you unique and valuable." Stay tuned for more inspiring reflections throughout the month! #WomensHistoryMonth #WomenInScience
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Are you ready to transform the way patient narratives are created? Join us on 𝗪𝗲𝗱𝗻𝗲𝘀𝗱𝗮𝘆, 𝗠𝗮𝗿𝗰𝗵 𝟮𝟲𝘁𝗵 𝗮𝘁 𝟭𝟬 𝗔𝗠 𝗘𝗧/ 𝟮 𝗣𝗠 𝗚𝗠𝗧 for an exclusive webinar on how cutting-edge technology is modernizing patient narrative writing. Discover how automation is saving time, reducing complexity, and enhancing accuracy for medical and regulatory teams. 𝗞𝗲𝘆 𝗧𝗮𝗸𝗲𝗮𝘄𝗮𝘆𝘀: ✅ Explore how technology can assist in patient narratives ✅ Learn how to automate and scale the narrative creation process ✅ See practical applications of automation through a real-world case study ✅ Gain actionable insights to simplify your regulatory writing processes Our expert speakers, Nirmal Reema Selvaraju and Christopher Kutzler, will share their knowledge, providing fresh perspectives and innovative strategies to empower your team. 🔗 Reserve your spot today and unlock the future of patient narrative writing: https://lnkd.in/eXMreYHC #MedicalWriting #PatientNarratives #RegulatoryWriting
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What if Artificial Intelligence could reshape how we develop life-saving medicines? Join us for an exclusive Cambridge Healthtech Institute (CHI) webinar, "Model-Informed Drug Development in the Age of AI," on April 3, 2025, at 11 AM EST. Discover how AI is transforming traditional drug development into a faster, smarter, and more efficient process. Key topics we'll explore include: ✅ Using AI to accelerate model validation and decision-making ✅ Deep learning applications in drug discovery and clinical development ✅ Regulatory perspectives on AI and its impact on evidence generation Don't miss out on insights from Certara's leaders Fran Brown, Piet Van Der Graaf, Ayman Akil, and Ian Kerman as they share progressive strategies and real-world applications of AI in pharmacology and drug development. Register Now: https://lnkd.in/drJjyDvF #AIinPharma #DrugDevelopment #CHIWebinar #CambridgeHealthInstitute
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Registration is open for our 4-day online PBPK boot camp for students, occurring July 21-24, 2025! https://lnkd.in/eGK_EQGt This boot camp is a unique opportunity to deepen your knowledge across Discovery, DMPK, Clinical Pharmacology, and Drug Development. Led by industry experts, the boot camp will provide practical insights into IVIVE-linked PBPK modeling, PK profile prediction, and drug-drug interactions. Our dedication to education doesn’t stop here—we offer monthly Simcyp workshops, certification courses, and on-site trainings designed to boost confidence and competency for both industry and academic users. 💡 Join us and take the next step in your scientific career by learning from leading professionals in the fieldr: https://lnkd.in/eGK_EQGt Browse all upcoming Simcyp workshops: https://lnkd.in/dSFp5cuD
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𝗣𝗿𝗲𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗦𝗮𝗳𝗲𝘁𝘆 𝗖𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲𝘀? 𝗜𝗻 𝗦𝗶𝗹𝗶𝗰𝗼 𝗧𝗼𝗼𝗹𝘀 𝗖𝗮𝗻 𝗛𝗲𝗹𝗽! At #SOT2025, Certara experts will showcase how predictive modeling and computational approaches enhance early risk assessment, helping you make safer, smarter decisions in drug development. Don't miss these sessions: 🧪 𝗔𝗿𝗲 𝗠𝗲𝘁𝗮𝗯𝗼𝗹𝗶𝘁𝗲𝘀 𝗼𝗳 𝗖𝗼𝗻𝗰𝗲𝗿𝗻? 𝗔 𝗧𝗶𝗲𝗿𝗲𝗱 𝗧𝗲𝘀𝘁𝗶𝗻𝗴 & 𝗔𝘀𝘀𝗲𝘀𝘀𝗺𝗲𝗻𝘁 𝗔𝗽𝗽𝗿𝗼𝗮𝗰𝗵 📅 March 18 | 8:40 AM - 9:15 AM | 📍 Room W203A Learn how the Riskhunt3R (RH3R) toolbox integrates in silico and in vitro tools for smarter metabolite risk assessment with Barira Islam, Sr. Research Scientist. 🔬 𝗗𝗲-𝗿𝗶𝘀𝗸𝗶𝗻𝗴 𝗦𝗺𝗮𝗹𝗹 𝗠𝗼𝗹𝗲𝗰𝘂𝗹𝗲 𝗣𝗶𝗽𝗲𝗹𝗶𝗻𝗲𝘀 𝗨𝘀𝗶𝗻𝗴 𝗜𝗻 𝗦𝗶𝗹𝗶𝗰𝗼 𝗧𝗼𝗼𝗹𝘀 📅 March 19 | 1:45 PM - 2:45 PM | 📍 Room W208B Join Will Redfern PhD Redfern, VP of QSTS, to explore how QSAR models and in silico tools predict risks—like hepatotoxicity and QTc prolongation—before they derail development. Let’s connect at SOT! Schedule a meeting in advance for a chance to win Apple AirPods: https://ow.ly/tVg450V9Kfm Visit Booth #1147 to explore Certara’s full presence: https://ow.ly/jEap50V9Kfn #SOT2025 #InSilicoToxicology #PreclinicalSafety #RiskAssessment #NAMs #DrugDevelopment #Toxicology #ComputationalToxicology #QSAR #PredictiveModeling
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Exciting news for #DIAEurope attendees! Stop by Booth F2 to see how #GlobalSubmit is transforming regulatory submissions. From simplifying processes to increasing precision, we’re showcasing the future of submission management. Want to experience it firsthand? Book your one-on-one demo or swing by to meet our team at DIA Europe 2025: https://lnkd.in/eTWwuaTs Transform your submissions. Drive innovation forward. We’re looking forward to connecting with you! 👋
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We’re currently exhibiting at the AI in Drug Discovery Conference in London! Stop by to discover how Certara.AI and the D360 Scientific Informatics Platform are transforming drug development. Learn about: - AI-powered breakthroughs in drug discovery - Streamlined R&D with innovative data solutions 📍 Visit us at our booth to connect and explore cutting-edge advancements shaping the future of drug discovery. #AIinDrugDiscovery #Certara #LifeSciences #DrugDevelopment
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Understanding FDA validation rules is critical for ensuring clinical data quality. But staying up to date with the latest requirements can be a challenge. Now you can navigate the rules without the stress! Certara expert Erin Erginer explains all in her latest blog, 'How to Validate Your Clinical Data Using FDA Validation Rules.' You’ll learn: ● How to ensure your submissions meet FDA standards ● How to minimize the risk of costly delays and rejections ● How tools like Pinnacle 21 Enterprise can help you take control of your validation process. Stay ahead of evolving regulations with expert insights💡 Read the blog here: https://lnkd.in/eQmfTtzX #ClinicalDataValidation #FDAValidationRules #Certara
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As a PK/PD researcher, you need fast, compliant solutions. Phoenix software solutions streamline NCA workflows with integrated analysis and CDISC-compliant reporting, while automating regulatory submissions for greater efficiency and scalability. Join us to see Certara’s industry-leading PK software Phoenix WinNonlin and PK Submit in action and discover how Phoenix can further optimize your research. https://lnkd.in/eJcEtEhQ
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